MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL STEM 12/14 NECK TAPER STD; PROSTHESIS, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hip Fracture (2349)

Event Date 06/18/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source : (b)(6).Concomitant medical products: catalog number: 010000707, lot number:3956515, brand name: g7 bonemaster shell.Catalog number:110003628, lot number:3883478, brand name: biolox delta ceramic liner.Catalog number: 00877503603, lot number:3001638, brand name: biolox delta ceramic head.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient fell from a standing position and required hospitalization.The patient underwent an open reduction internal fixation (orif) with a plate placement due to periprosthetic fracture approximately 7 months post implantation.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

Upon receipt of additional information it has been determined that the reported device did not cause or contribute to the event.

Manufacturer Narrative

Upon receipt of additional information it has been determined that the reported device did not cause or contribute to the event.Patient fell due to development of sciatica that was affecting the left leg (the non operative leg).This is a pt anatomy/ pt comorbidity issue that is not device or procedure related as it developed months postoperatively, the prosthesis does not come in contact with the sciatic nerve, and it was the contralateral/opposite leg that was affected.Sciatica refers to pain that radiates along the path of the sciatic nerve, which branches from your lower back through your hips and buttocks and down each leg.Typically, sciatica affects only one side of your body.Sciatica most commonly occurs when a herniated disk, bone spur on the spine or narrowing of the spine (spinal stenosis) compresses part of the nerve.This causes inflammation, pain and often some numbness in the affected leg that often times causes the leg to give out.

• Brand Name: FEMORAL STEM 12/14 NECK TAPER STD
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 10225174
• MDR Text Key: 197541856
• Report Number: 0002648920-2020-00331
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K960658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00811400218
• Device Lot Number: 63456955
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/22/2020
• Initial Date FDA Received: 07/02/2020
• Supplement Dates Manufacturer Received: 10/15/2020
• Supplement Dates FDA Received: 10/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 131